Customer Outcomes & Value Experiencing A New Monitoring Technology

NCT ID: NCT04262700

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-07

Study Completion Date

2020-10-01

Brief Summary

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To investigate whether novel insight features in new Blood Glucose Monitoring System (BGMs) can improve glycemic control.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention 01

Subjects use new LifeScan provided BGMS for 12 weeks.

Group Type EXPERIMENTAL

LifeScan's new BGMS

Intervention Type DEVICE

LifeScan new Blood Glucose Monitoring System (BGMS)

Interventions

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LifeScan's new BGMS

LifeScan new Blood Glucose Monitoring System (BGMS)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with Type 1 diabetes mellitus or Type 2 diabetes mellitus for ≥ 3 month prior to screening
* Currently performing self-monitoring of blood glucose (SMBG) at home for diabetes management decisions
* Willingness to notify the study staff if they become pregnant during the study
* Willing to sign an informed consent

Exclusion Criteria

* Currently using a continuous or flash glucose monitoring
* Currently pregnant or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn.
* Conflict of Interest
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LifeScan Scotland Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Royal Infirmary of Edinburgh

Edinburgh, Lothian, United Kingdom

Site Status RECRUITING

Highland Diabetes Institute

Inverness, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Mike Grady

Role: CONTACT

01463 721000

Kirsty Macleod

Role: CONTACT

Facility Contacts

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Alison Sudworth

Role: primary

David MacFarlane, MD

Role: primary

Other Identifiers

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FILE-PROT-005120

Identifier Type: -

Identifier Source: org_study_id

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